Clinical Trial to Evaluate the Effect of a Probiotic in Acne

Sponsor

Bionou Research, S.L. (Other)

Overall Status

Recruiting

CT.gov ID

NCT04570319

Collaborator

(none)

Enrollment

Locations

Arms

29.1

Anticipated Duration (Months)

Patients Per Site

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

A 12-week randomized, multicenter and double-blind, placebo-controlled pilot study to evaluate the effect of a probiotic in the clinical and subjective evolution of acne in adolescent and adult patients.

Condition or Disease	Intervention/Treatment	Phase
Acne Acne Vulgaris	Dietary Supplement: Probiotic Bths-08 Dietary Supplement: Placebo	N/A

Detailed Description

Acne is a chronic inflammatory disease of the skin that affects 85% of younger adults in westernized populations. Acne pathophysiology is multifactorial and may include alterations of the pilosebaceous unit function, skin microbiota, hormone imbalance and gut microbiota. Acne pathology shares features with inflammatory chronic conditions such as metabolic syndrome, obesity or diabetes.

Probiotics are live microorganisms that when administered in adequate amounts confer a health benefit for the host. Probiotics are proposed for the treatment of inflammatory chronic conditions, including dermatological diseases as atopic dermatitis and psoriasis. However, the clinical evidence is limited. Therefore, usefulness of probiotics for acne vulgaris treatment must be ascertained in humans.

This randomized study aims to evaluate the effect of a probiotic on the treatment and clinical and subjective evolution of acne vulgaris.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Treatment

Official Title:

A Randomized, Double Blind and Placebo-Controlled Clinical Trial to Evaluate the Effect of a Probiotic in Patients With Acne

Actual Study Start Date :

Apr 29, 2020

Anticipated Primary Completion Date :

Jul 1, 2022

Anticipated Study Completion Date :

Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Probiotic Bths-08 a capsule containing the probiotic blend (nutritional complement)	Dietary Supplement: Probiotic Bths-08 A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks
Placebo Comparator: Placebo a capsule containing placebo comparator	Dietary Supplement: Placebo A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks

Arm

Intervention/Treatment

Experimental: Probiotic Bths-08

a capsule containing the probiotic blend (nutritional complement)

Dietary Supplement: Probiotic Bths-08

A capsule containing the probiotic blend (dietary supplement), administered once daily for 12 weeks

Placebo Comparator: Placebo

a capsule containing placebo comparator

Dietary Supplement: Placebo

A capsule containing the placebo (dietary supplement), administered one daily for 12 weeks

Outcome Measures

Primary Outcome Measures

Change from baseline in the AGSS (Acne Global Severity Scale) index at 12 weeks [0 and 12-week]
Score between 0 and 5: 0: Clean = Normal and clear skin without evidence of acne Almost clean = There are some non-inflammatory lesions, with uncommon and non-inflamed papules Mild = few inflammatory lesions (no nodule-cystic lesions) Moderate = Noninflammatory lesions predominate, but multiple inflammatory lesions appear (nodule-cystic lesions may be present) Severe = Inflammatory lesions predominate (nodule-cystic lesions may be present) Very severe = Highly inflammatory lesions predominate (several nodule-cystic lesions)
Change from baseline in the GAGS (Global Acne Grading System) index at week 12 [0 and 12-week]
TOTAL SCORE = [Nose S x 1 + Chin S x 1 + Front S x 2 + Right cheek S x 2 + Left cheek S x 2 + Torso S x 3] [Severity (S): 0 = Absence; 1 = Comedones; 2 = Papules; 3 = Pustules; 4 = Nodules] SCORE: 0 = Clean; 1-18 = Mild; 19-30 = Moderate; 31-38 = Severe; > 38 = Very severe
Change from baseline in the number of acne lesions at week 12 [0 and 12-week]
Number of non-inflammatory, inflammatory and total acne lesions.

Secondary Outcome Measures

Change from the baseline in the patient subjective evaluation index at week 12 [0 and 12-week]
Min score (Best) = 6 Max score (Worst) = 30
Use of antibiotic acne treatment [12-week]
Days of antibiotic use for the acne treatment, registered by the patient.
Change in the percentage of patients with presence of Cutibacterium acnes and Staphylococcus aureus in skin microbiome [0 and 12-week]
Skin sample and genomic and microbiological analysis.
Change in the microbiome components on stool samples [0 and 12-week]
Stool sample and high-throughput sequencing data analysis.
Adherence to treatment [12-week]
Compliance rate (in percentage) calculated as the number of leftover capsules divided by the total number of days between visits.
Treatment safety assessed by number of adverse events [12-week]
Number of adverse events that occur during the treatment period.

Eligibility Criteria

Criteria

Ages Eligible for Study:

12 Years to 30 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Signature of informed consent by the patient (and their legal guardian in case of being under age).
Age between 12 and 30 years-old.
AGSS (Acne Global Severity Scale) Score: 2 or higher
Patients who agree to follow the study's dietary recommendations.

Exclusion Criteria:

Contraindication of any of the components of the product under study.
Topical or systemic use of antifungals and antibiotics in the previous 2 weeks.
Consumption of probiotics in the previous 2 months.
Use of systemic retinoids in the previous 6 months.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidad Católica San Antonio de Murcia	Guadalupe	Murcia	Spain	30107
2	Centro Dermatológico Estético de Alicante	Alicante		Spain	03014
3	Clínica Eguren Dermatología y Estética	Madrid		Spain	28006
4	Hospital Vithas Nisa 9 de Octubre-Valencia	Valencia		Spain	46015